MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 303 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793194001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode lot number was fbv83 with an expiration date of 13-sep-2026.The calibration and qc data were provided, and they were acceptable.The alarm trace showed a sample pipetter alarm and multiple abnormal aspiration alarms noted on the date of the event, around the time the sample was processed.The field service engineer (fse) found that the customer skipped the maintenance by cleaning salt crusting from the reference electrode with deionized water, executing an ion-selective electrode (ise) flow path wash, and purging air bubbles with reagent primes.The fse educated the user on the required three-month maintenance frequency, an ise check and qc were performed, and they were within specifications.The patient sample was tested, resulting in a value aligned with the expected clinical values.The fse verified that the instrument was performing within specifications.The cause of the event was due to an improper product handling by the customer (not performing the quarterly maintenance function).
Event or Problem Description
We received an allegation of questionable sodium electrode results for 1 patient sample tested on a cobas c 303 analytical unit.Initial result: 129 mmol/l.The provider questioned the initial result, prompting the repeat of the sample.Repeat result: 135 mmol/l.The repeat result was deemed to be correct.

• Brand Name: COBAS C 303 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25408223
• Report Number: 1823260-2026-02217
• Device Sequence Number: 10749117
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09793194001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown